Complete FDA and NHTSA recall records dated in July 2021.
These records include useful source details for the selected month.
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an FDA approved drug making this an unapproved drug for which the safety and efficacy has not…
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sildenafil, and vardenafil, FDA approved drugs making them an unapproved drug for which the…
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and…
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Kia Motors America (Kia) is recalling certain 2022 Telluride vehicles. The LCD display screen may remain blank after startup. As such, these vehicles fail to comply with the requirements of…
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may…
No 510(k) clearance
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not…
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas…
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
